510(k) Report

Devices descending from K042498

188 later devices reach Vertex Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062934SierraSeaspine, Inc.200621—
+1K052734Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek2005175—
+1K052180Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2005187—
+2K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+2K133698Synapse SystemSynthes USA Products, LLC20146—
+2K121979Pass Oct Spinal SystemMedicrea International201314—
+2K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+2K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+2K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek2009138—
+2K072729SierraSeaspine, Inc.20085—
+2K080526Sierra SystemSeaspine, Inc.20089—
+2K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076—
+2K071942Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek200724—
+2K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+2K062879Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc.2006151—
+2K060683Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.200632—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K231654NorthStar OCT SystemSeaspine, Inc.20230—
+3K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+3K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+3K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+3K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+3K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+3K150918PASS OCT Spinal SystemMedicrea International SA201513—
+3K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc.20150—
+3K140734Nextgen Altius Oct SystemEbi, LLC20140—
+3K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+3K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+3K131427LOTUSSpinal Elements, Inc.20130—
+3K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+3K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+3K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+3K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+3K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+3K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+3K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+3K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+3K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095—
+3K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+3K070282Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.200731—
+4K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+4K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+4K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+4K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+4K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+4K161149PASS OCT Spinal SystemMedicrea International SA20160—
+4K160756PASS OCT Spinal SystemMedicrea International SA20160—
+4K153169PASS OCT Patient Specific RodsMedicrea International20164—
+4K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+4K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+4K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+4K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+4K120998Solstice Cross ConnectorLife Spine20121—
+4K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+4K113346Neon SystemUlrich GmbH & Co. KG20121—
+4K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+4K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+4K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20103—
+4K080258Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.20080—
+4K073267Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.20080—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K233366SYMPHONY OCT SystemMedos International SARL20230—
+5K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+5K230614Cortium™Ulrich Medical USA20230—
+5K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+5K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+5K182182YUKON OCT Spinal SystemK2m20185—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K162575Z-LINKPC SystemZavation, LLC20173—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+5K152211PCT SystemCentinel Spine, Inc.20150—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+5K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K141284Caspian Spinal SystemK2m, Inc.20140—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K131833Centurion Poct SystemOrthofix, Inc.20142—
+5K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—